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NCT03956615 · REGISTRY CONDITION SEARCH

sdAb-based TRNT of Multiple Myeloma: a Feasibility Study

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2021-12-01

This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.

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outcome · POSTED

Amount of Paraprotein-targeting sdAbs Generated Per Patient

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: Patients will only be included in the study if they meet all of the following criteria: * Patients who have given informed consent * Patients at least 18 years old * Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma. Exclusion Criteria: Patients will not be included in the study if one of the following criteria applies: * Patients who cannot communicate reliably with the investigator * Patients who are unlikely to cooperate with the requirements of the study * Patients at increased risk of death from a pre-existing concurrent illness * Patients who participated already in part I of this study
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients with a clinically suspected or pathologically confirmed multiple myeloma.
    intervention Names
    1. Other: Blood sampling and bone marrow analysis
    label
    Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
    type
    OTHER
interventions
  1. arm Group Labels
    1. Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
    description
    Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)
    name
    Blood sampling and bone marrow analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
OTHER
Enrollment
count
10
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
    measure
    Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
    time Frame
    Within 2 years after study completion
  2. description
    Absolute amount of unique sdAbs obtained per patient
    measure
    Amount of Paraprotein-targeting sdAbs Generated Per Patient
    time Frame
    Within 2 years after study completion
Full study description
brief Summary
This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a796030ac45274d33c7d
      requested nct id
      NCT03956615
      primary nct id
      NCT03956615
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      payload sha256
      f566ea30214fdbe53c1bfd15a42b79e2d84e7f0fc73c908cf46b13eae45a836d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a796030ac45274d33c7d
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03956615
      occurrences
      1. context exact
        NCT03956615
        end
        11
        exact text
        NCT03956615
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-001.json
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      source json pointer
      /studies/36/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      c838cc9848c7f2286d9ea09998e5abac0c36d120f56b1c612b366fa37cc48f35

    Preserved source evidence · Not medical advice